Clinical application of oral form of ANGIPARS™ and in combination with topical form as a new treatment for diabetic foot ulcers: A randomized clinical trial

Abstract

ANGIPARS™ is a new herbal extract which has been produced in oral, topical, and intravenous forms. The present article contains preliminary results of the study which was planned to evaluate the efficacy and safety of orally applied ANGIPARS™ and to compare it with the combination of oral and topical forms and also with conventional therapy in patients with diabetic ulcers of the lower extremities. Twenty one patients with diabetic foot ulcers were divided into 3 groups. The first group received 100 mg of oral ANGIPARS™ twice a day for 6 weeks in addition to conventional therapies. In the second group, ANGIPARS™ gel 3% was added to the oral form of the same product besides the conventional therapies for the same period of time. Finally, in the third group which was considered as control, only conventional therapies were performed. The patients were followed for 6 weeks. Parameters such as granulation tissue formation, skin epithelization, and wound surface areas changes were analyzed to determine the effectiveness of the compound in wounds healing. Furthermore, drug safety was assessed by monitoring adverse events and by clinical and laboratory evaluations. The study data showed significant differences between the intervention and control groups with respect to efficacy and tolerability. In each intervention group, primary wound healings occurred following 2 weeks. Complete wound healing which was greater than 70% improvement in wounds surface areas was achieved in 83% and 100% of group 1 and group 2 participants, respectively after 6 weeks. On the other hand, at the same period of time, only 22.2% of patients in control group revealed complete healing. Therefore, ANGIPARS™ had significant positive effect in increasing the incidence of complete wound closure compared with control group (p = 0.042). However, our evaluations indicated that adding topical treatment with 3% gel once a day to the oral therapy with the same product did not make significant difference in healing outcomes statistically (p = 0.769). Clinical and paraclinical evaluations did not show any adverse events during the study. This study showed that in diabetic foot ulcers, either treatment with oral ANGIPARS™ capsules (100mg) twice a day or combination therapy with oral and topical forms, in conjunction with good wound care significantly increased the incidence of complete wound closure. In addition, the application of this product was safe and did not make any unexpected adverse event.